Surpass, Inc. is a preclinical contract research organization in the greater Twin Cities area, near the medical device cluster around Minneapolis and St. Paul. It describes itself as "a trusted partner and contract research organization (CRO) specializing in preclinical services for medical devices, drugs, pharmaceuticals, biologics, and combination products,"[S1] and states that its team "has successfully serviced the global Biomedical Community for more than 20 years."[S1] Its work is surgical and interventional: large animal studies and human cadaver studies rather than rodent toxicology. This profile summarizes the services, models, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug and device developers
Surgical and interventional in vivo studies
The company organizes its work around eleven named clinical areas: cardiac covering structural heart and electrophysiology, dermal, gastrointestinal, general and reconstructive surgery, neurological, oncology, orthopedic and spine, respiratory, urogenital, vascular, and wound healing and traumatic injury, plus a track for de novo and disruptive technologies.[S7] It states that "our experience spans everything from early feasibility through GLP safety studies, including assessments of performance, biocompatibility, efficacy, human factors, and more."[S7] Species used are "rabbits, pigs, sheep, calves, dogs, and goats."[S5] Named models on the research page span abdominal compartment syndrome, aneurysm, benign prostatic hyperplasia, cardiopulmonary bypass, cartilage, ligament and tendon injury, cerebral stroke and trauma, chronic total occlusion, congestive heart failure, coronary artery bypass grafting, in-stent restenosis, lung volume reduction, myocardial infarction, organ resection and transplant, sepsis, thrombus and deep vein thrombosis, Vx2 tumor and wound healing.[S5]
Human cadaver studies and bio-skills training
Alongside animal work the company offers human cadaver studies and physician training. It states that it "can also source serologically tested human cadaver models with disease states of interest for your preclinical research studies or bio-skills clinical training,"[S5] including specimens with conditions such as coronary or peripheral artery disease or osteoporosis, or with previously placed devices such as stents, grafts and pacemakers, and can set up vascular flow loops on request.[S5] For device developers this is often where early design feedback is obtained before an animal study is committed.
Pathology and analytical testing are delivered through partners
Histopathology and analytical testing are not performed in house. The company states that it "works with experts in their respective fields to conduct histopathology and analytical testing required for in vivo studies,"[S6] naming external partners for gross pathology, histology processing and drug content analysis.[S11] Analytical work listed includes "drug content testing on devices, blood, tissues and urine."[S6] Sponsors should establish which organization holds the study, which holds the pathology phase, and how the quality system applies across both.
Quality, compliance, and animal welfare (as stated by the company)
GLP with the regulation named. The quality page lists the regulations the company works to: "Good Laboratory Practice (GLP) Regulations 21 CFR Part 58 for Safety Studies," "Animal Welfare Act and Animal Welfare Regulations 9 CFR Parts 1-4," and "Electronic Records 21 CFR Part 11."[S3] On the services side the company states that it has "developed an international reputation as a GLP-compliant lab and the preclinical CRO-of-choice to conduct GLP studies for supporting successful regulatory and clinical submissions"[S4] and cites "hundreds of GLP preclinical studies under our belt, positive FDA inspection results, and technical expertise across numerous medical disciplines."[S4] The inspection claim is the company's own summary with no dates or classifications published; FDA inspects nonclinical laboratories under its Bioresearch Monitoring program but does not approve or certify laboratories.[R6] GLP compliance applies study by study, so sponsors should confirm the scope in the protocol.[R2]
Accreditation and animal welfare. The company states that "Surpass facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International."[S3] Two points of wording are worth noting. On USDA the site uses "USDA-compliant" for its animal housing[S2] rather than stating that it is a USDA-registered research facility, and no registration number is published. On OLAW it states that it "maintains Office of Laboratory Animal Welfare (OLAW) Assurances on file for National Institutes of Health (NIH)-funded projects,"[S3] which is scoped to NIH-funded work rather than presented as a blanket assurance. The term IACUC was not found on any of the pages reviewed, although the company does state that it "is committed to the ethical treatment and humane care of laboratory animals."[S3] It also states that it "regularly performs Department of Defense (DOD)-funded studies."[S3] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6] This profile does not evaluate the company's animal care program; the statements above are the company's own.
Described as the Midwest, greater Twin Cities area. No street address is published on the website; press releases from 2013 and 2014 carry an Osceola, Wisconsin dateline[S2][S10]
Founded
Not stated; the company cites more than 20 years serving the biomedical community[S1]
Ownership
Private; no investor or stock listing is disclosed[S1]
President and CEO
Tim Pelura, PhD, appointed effective December 16, 2013[S10]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise
In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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